In 6 months (around June 2024) the FDA (US medicine regulator) will likely approve MDMA (ecstasy) as a licensed medicine in the US. This will present a pivotal moment for mental health care around the world as the efficacy rates of MDMA relative to traditional treatments for PTSD, depression and addictions are impressive.

As you can see from above, the most recent data indicates high rates of remission from PTSD (red) with MDMA in comparison to placebo (blue). Further comparing these rates (see picture below) to traditional antidepressant effectiveness rates i.e. from 19 to 70% within SSRIs (Prozac et al.), from 31 to 70% within the SNRI (Duloxetine et al.) treatment arms, and from 23 to 54% within TCAs (Amitriptyline et al.).

This may not seem very impressive, however, there is one major distinction, MDMA is curative. The importance of this cannot be stressed enough. Aside from the cost of having to take traditional antidepressants every day which comes with a wide range of side effects, such as with, TCAs treatment: dry mouth (58%), sweating (28%) and constipation (26%)² there’s the additional burden of anhedonia (not being able to feel anything good, or bad!).

MDMA is different. The medicine treats the root cause of the disease instead of just tranquilising the symptoms such as poor mood or lack of motivation. MDMA does this through a process known as fear memory extinction, which modulates fear memory consolidation. At its simplest, this means MDMA can dissolve bad feelings associated with a memory which in extreme cases is termed trauma. This makes it more comparable to traditionally stronger, last-line treatments like ECT which has its major side effects of memory loss.

When will MDMA be available in Australia?

Well in theory, due to the changes put forth by the TGA on 1 July 2023, it should already be available. However, due to the huge amount of red tape and high demand, the vast majority of 1 in 7 depressed patients in Australia cannot get access. This is why the licensing by MAPS is so important, it puts the medicine in a licensed category meaning, that doctors will have better coverage by indemnity insurance if something were to go wrong, therefore, they will have a higher propensity to prescribe. i.e. the risk to them is a lot lower and therefore, given the demand this should cause an upsurge in supply.

So where to go from here? Stay updated with the latest developments. Whilst it’s likely the FDA will license the medicine in the US in June, it will take a bit of time to come to Australia (usually another 6 months). At this point, it is more than likely it will be considered a Controlled Drug and hopefully be prescribable by regular doctors (however this may be limited to psychiatrists only). By whichever route, it should be available this time next year, for a high price due to the overwhelming demand, this is why we have created the Psychedelic Buyers Club to ensure a lower cost via a bulk buy.

References

¹ MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Published in the Nature Medicine Journal: 10 May 2021: Jennifer M. Mitchell. Accessed on 2 January 2024 via: https://www.nature.com/articles/s41591-021-01336-3

² Tricyclic Antidepressants. Moraczewski J, Awosika AO, Aedma KK. [Updated 2023 Aug 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557791/

³ Remission, dropouts, and adverse drug reaction rates in major depressive disorder: a meta-analysis of head-to-head trials. Review published: 2006. Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. M Machado, M Iskedjian, I Ruiz, and TR Einarson. https://www.ncbi.nlm.nih.gov/books/NBK73259/

Note: As of October 2023, psilocybin remains a Class A drug in the UK. The following article provides informational content and does not endorse or encourage illegal activities. Always adhere to local laws and regulations.

Introduction

The world of mental health treatments is rapidly evolving, and among the emerging therapies are psilocybin as a medicine. Traditionally psilocybin is consumed as the dry weight of magic mushrooms, however, in recent years, as there has been an explosion in clinical trials of psychedelics; psilocybin has been isolated / manufactured and formulated as pills.

1. Psilocybin: A Brief Overview

Psilocybin is a naturally occurring compound found in certain mushrooms. Historically used in ritualistic and spiritual contexts, modern science is now exploring its potential therapeutic benefits, especially for conditions like depression and anxiety.

2. Legal Status in the UK

In the UK, psilocybin is currently classified as a Class A drug. This classification makes its production, possession, and supply illegal. However, for research purposes, certain exceptions may apply, given the proper licensing and permissions.

3. The Rise of Psilocybin Pills

While traditional consumption methods involved eating raw mushrooms, advancements have led to the extraction and encapsulation of psilocybin into pill form. These pills offer a controlled dosage, making them more suitable for therapeutic and research settings.

4. Ongoing Research and Trials

The UK has been home to several groundbreaking studies on psilocybin. Prestigious institutions are delving into its efficacy as a treatment for various mental health disorders. Preliminary results have shown promise, though extensive research is still needed.

5. The Future of Psilocybin Pills in the UK

Given the growing body of evidence supporting the therapeutic potential of psilocybin, there is hope that regulations might evolve. However, any changes would require rigorous scientific backing, coupled with societal and political will.

Conclusion

Psilocybin pills in the UK represent a fascinating intersection of tradition, science, and regulation. As research progresses and our understanding deepens, the landscape may shift, offering new avenues for mental health treatments. Until then, it’s crucial to stay informed, adhere to current laws, and watch this space for developments.

As of the last update of this article in October 2022, psilocybin remains a Class A drug in the UK, making it illegal to produce, supply, or possess. The following article is meant for informational purposes only and does not endorse or encourage illegal activities. Always consult with local laws and regulations.

Introduction

Psilocybin, the active compound found in certain mushrooms, has been the subject of much medical and scientific interest in recent years. While it remains a controlled substance in many countries, the potential therapeutic applications of psilocybin are being explored extensively. If you’re interested in understanding the process of obtaining a psilocybin prescription in the UK, here’s what you need to know.

1. Understanding Psilocybin’s Legal Status

Before diving into the intricacies of obtaining a prescription, it’s essential to be clear about psilocybin’s legal status. In the UK, psilocybin mushrooms are classified as a Class A drug. This means it’s illegal to possess, produce, or supply them. Any attempt to procure psilocybin without appropriate authorisation can lead to severe legal consequences.

2. The Potential Therapeutic Uses

Research studies have shown that psilocybin may have potential therapeutic effects, particularly for conditions like depression, anxiety, and PTSD. Clinical trials are underway in various parts of the world to better understand its safety and efficacy.

3. Special Licences for Research

While general possession and supply are prohibited, specific licences can be granted for research purposes. Institutions or researchers looking to study psilocybin’s therapeutic effects can apply for such a licence from the UK Home Office.

4. Consulting with a Healthcare Professional

If you believe that psilocybin might be beneficial for your health, it’s crucial to consult with a healthcare professional. They can provide guidance on potential treatment options, risks, and the legal aspects surrounding psilocybin in the UK.

5. Staying Updated with Changing Regulations

Laws and regulations around controlled substances can evolve. It’s vital to stay informed about any changes in the legal status of psilocybin or its potential therapeutic applications in the UK.

Conclusion

While the therapeutic potential of psilocybin is promising, it remains a controlled substance in the UK. Those interested in its benefits should approach the topic with caution, always prioritising legal considerations and consulting with healthcare professionals. By staying informed and adhering to regulations, individuals can navigate this complex landscape safely and responsibly.

There are some exceptions to this rule, such as in the case of telemedicine, where a healthcare provider may prescribe controlled substances via a video call if certain conditions are met. However, the use of psychedelics for medical purposes is still highly regulated and not widely accepted.

One recent example of poor online prescribing practice is a story of a patient who was prescribed 75 doses of Ketamine in 5 minutes online which was then delivered to his house for under $300. Whilst providing access to low-cost medicine for patients is an ethical virtue of practice one should keep in mind that there is an online prescribing best practice which should be followed. This includes online prescribing risk analysis and subsequent mitigation which should be performed after each medicine is added to an online prescribing formulary.

However, if proper safeguards are in place there are a wide range of opportunities in the medical space, including:

• Psilocybin availability in the UK

If you would like more information concerning these opportunities you can contact one of our expert consultants here.

Two academic disciplines that look at how non-biological variables affect the response to therapy are placebo response theory and set and setting theory. Both believe that aspects like expectations, planning, and beliefs are essential for comprehending the extra-pharmacological processes that determine how the body responds to medications.

But the two theories also have important distinctions of their own. Set & setting only considers how people react to psychoactive medications; placebo theory applies to all forms of treatment. Set and setting theory is intended for both experts and drug users, whereas placebo theory is targeted at medical professionals. Set and setting theory is mostly prescriptive, teaching therapists and users how to regulate and maximise the effects of medications, whereas placebo theory is primarily descriptive, explaining how placebo operates.

Although the precise interactions between these two perspectives still need to be clarified, when taken together, the advantages of their combined consideration become clear: While placebo theory suggests that psychedelics, as suggestibility-improving, meaning-magnifying substances, may serve to boost placebo response, set and setting theory gives a paradigm for the reintegration and optimisation of placebo response in clinical practice.

One retrospective study conducted in 2010, looked at how SSRIs might affect people’s personality in the long run as the medicine has been shown to alter the concentration of a key neurotransmitter serotonin. The reason for this is that it has been found that neurotransmitters instead of working like a golden bullet on one aspect of the mind such as regulating depression work in synergy to maintain a whole host of characteristics. By just changing one instruments volume in the neurotransmitter symphony of self can put people on a very different path in your life. Serotonin has been shown to selectively influence moral judgment and behavior through effects on harm aversion¹. Furthermore, another very popular set of medicines the statins has shown to potentially do the opposite, i.e. instead of increasing the the concentration of serotonin like what the SSRIs do they decrease their concentration. This has led to a significant association between low or lowered cholesterol levels and violence is found across many types of studies².

This example is one of many retrospective studies showing the long term unintended personality changes caused by medicines, others include:

• Heartburn pills Among the most commonly used drugs in the world, proton pump inhibitors used to treat heartburn and acid reflux have been linked with a greater risk of developing depression, particularly among the elderly. They interfere with the absorption of vitamin B12, a nutrient that produces chemicals that affect our thinking.
• Asthma and arthritis drugs Corticosteroids such as prednisone can save lives – their powerful anti-inflammatory effect treats asthma, allergies and rheumatoid arthritis. But they can also cause depression, mania and ADHD, because they act on areas of the brain that regulate serotonin and dopamine – our ‘happy’ hormones.
• Parkinson’s drugs A 2010 study showed 17 per cent of people on dopamine agonists – used to treat shaking and other physical symptoms of Parkinson’s – experience ‘impulse control disorder’, from excessive shopping to uncontrollable sexual urges. In 2011 a married father of two sued the manufacturer of one of these drugs, saying it turned him into a gambling and gay sex addict, which led to him being raped and attempting suicide eight times. He won a six-figure payout.
• Antibiotics Overuse can make antibiotics less effective at treating infection – and a 2015 review of UK medical records linked repeat courses of antibiotics to increased anxiety and depression. It’s thought this may be down to their effect on bacteria in our guts, which interact with our brain chemistry.

References

¹Crockett MJ, Clark L, Hauser MD, Robbins TW. Serotonin selectively influences moral judgment and behavior through effects on harm aversion. Proc Natl Acad Sci U S A. 2010 Oct 5;107(40):17433-8. doi: 10.1073/pnas.1009396107. Epub 2010 Sep 27. PMID: 20876101; PMCID: PMC2951447, accessed on 21st January 2022 via: https://pubmed.ncbi.nlm.nih.gov/20876101/

² Golomb BA. Cholesterol and violence: is there a connection? Ann Intern Med. 1998 Mar 15;128(6):478-87. doi: 10.7326/0003-4819-128-6-199803150-00009. PMID: 9499332., accessed 21st January 2022 via https://pubmed.ncbi.nlm.nih.gov/9499332/